Efficacy of denosumab co-administered with vitamin D and Ca by baseline vitamin D status
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ORIGINAL ARTICLE
Efficacy of denosumab co‑administered with vitamin D and Ca by baseline vitamin D status Toshitsugu Sugimoto1 · Toshio Matsumoto2 · Takayuki Hosoi3 · Masataka Shiraki4 · Makiko Kobayashi5 · Naoki Okubo6 · Hideo Takami7 · Toshitaka Nakamura8 Received: 24 March 2020 / Accepted: 6 June 2020 © The Japanese Society Bone and Mineral Research and Springer Japan KK, part of Springer Nature 2020
Abstract Introduction In anti-osteoporosis drug trials, vitamin D and calcium (Ca) are common supplements; however, the optimal dose of each is unclear. Using data from the randomized, double-blind, placebo-controlled DIRECT trial, we assessed whether baseline serum 25-hydroxy vitamin D (25[OH]D) level influences the efficacy of denosumab co-administered with vitamin D and Ca. Materials and methods In this prespecified sub-analysis, subjects with primary osteoporosis who received denosumab or placebo, plus vitamin D (≥ 400 IU/day) and Ca (≥ 600 mg/day), were classified as 25(OH)D deficient ( 20 ng/mL of serum 25(OH)D [26]; however, in the DIRECT trial, at least 400 IU/day vitamin D was administered regardless of serum 25(OH)D concentration [27]. Ca dosage was not adjusted in either study based on 25(OH)D. Furthermore, whether baseline serum vitamin D levels have an impact on denosumab effects, such as BMD increase and fracture risk reduction, is unknown. Using data from the DIRECT trial, this study assessed the changes in serum 25(OH)D level and the effects of denosumab co-administered with vitamin D and calcium on BMD and fracture risk according to baseline 25(OH) D level.
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Journal of Bone and Mineral Metabolism
Materials and methods Study design The DIRECT trial (NCT00680953) was a randomized, double-blind, placebo-controlled trial. The complete study methodology has been described previously [27]. In brief, denosumab 60 mg or matching placebo was administered subcutaneously every 6 months during a 24-month period (at 0, 6, 12, and 18 months) in a double-blind manner. All subjects who received denosumab or placebo also received daily supplements containing Ca ≥ 600 mg and vitamin D ≥ 400 IU throughout the study period. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki, the International Conference on Harmonization E6 guideline for Good Clinical Practice, and all applicable national ordinances. Approval was obtained from the Institutional Review Board at each study center, and informed consent was obtained from all individual participants included in the study. The detailed inclusion and exclusion criteria have been described [27]. Subjects with one to four prevalent vertebral fractures and a BMD T-score of less than − 1.7 (Young Adult Mean in Japan 80%) at the lumbar spine or − 1.6 (Young Adult Mean in Japan 80%) at the total hip by dual-energy X-ray absorptiometry (DXA) based on the diagnostic criteria of primary osteoporosis in Japan [28] were included in the DIRECT trial. Subjects with serum 25(OH)D levels
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